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FDA PRODUCT CODE · CLASS II

QHC — Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.1075
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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